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Amid rising concerns about the risk of anaplastic large-cell lymphoma (ALCL) from breast implants, which appears to be linked to certain implants with texture surfaces, French health officials will hold hearings to determine what regulatory actions may be necessary.
The French National Agency for Medicines and Health Products (L’ANSM) issued a statement (in French) on November 21, indicating that health experts, health professionals and other stakeholders on breast implant safety will participate in hearings on February 7 and 8, which may result in a pan on certain types of breast implants that appear to increase the risk of cancer developing in the surrounding tissue.
In recent years, a number of women worldwide have been diagnosed with a rare type of cancer that is widely referred to has breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
French health officials said in the statement they have been tracking cases in that country since 2011, indicating that there have been at least 53 cases of BIA-ALCL, the vast majority of which were linked to textured breast implants.
Investigators say they have conducted numerous investigations and brought together experts from a wide variety of fields to analyze the problem. The announcement calls for applications by stakeholders wishing to participate in the hearings.
After the hearings, L’ANSM indicates it will make a decision on the use of textured breast implants in both aesthetic and reconstructive surgery.
In the interim, the agency recommends health care professionals avoid textured implants and steer patients toward smooth-surfaced implants.
Breast Implant Cancer Concerns In the U.S.
On January 26, 2011, in the U.S. the FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and ALCL.
The agency then issued a statement about emerging information on the breast implant lymphoma problems last year, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.
In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.
As regulators and researchers worldwide continue to evaluate the specific cause of the breast implant lymphoma problems, other women are also raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.
Product liability lawyers in the U.S. are now reviewing other potential breast implant cancer lawsuits for women diagnosed with anaplastic large cell lymphoma (ALCL) in recent years, alleging that manufacturers knew or should have known about the risk, yet withheld warnings from consumers and the medical community.